Dermira’s Acne Medication Olumacostat Glaseretil Tanks in Two Phase III Trials

Going into Phase III trials, Menlo Park, California-based Dermira, Inc. and numerous investors were optimistic about the company’s olumacostat glasaretil for acne. Unfortunately, the drug failed to meet its co-primary endpoints, a fairly spectacular flameout.

The co-primary endpoints of CLAREOS-1 and CLAREOS-2 were absolute changes from baseline in counts of inflammatory and non-inflammatory lesion counts, and the proportion of patients achieving at least a two-grade improvement from baseline based on a five-point scale. Which sounds like investigators were counting zits.

The drop in inflammatory lesions from baseline to 12 weeks in patients receiving the drug were 14.3 and 16.6, respectively, compared to 13.7 and 15.3 in "corresponding vehicle groups." For non-inflammatory lesions in the same period, patients receiving the drug in two trials were 14.8 and 17.8 compared to 11.2 and 17.4 in patients in the corresponding vehicle groups. Basically, the results were very close to the placebo arm.

"We are surprised and extremely disappointed by the results of the Phase III program," said Tom Wiggans, Dermira’s chairman and chief executive officer of Dermira in a statement. "This is disappointing not only for the company, but also for patients who are living with this condition and dermatologists who have been looking for novel therapies to treat them."

That was his diplomatic way of putting it. To STAT News’s Adam Feuerstein, Wiggans said, "Failure sucks. This is a big disappointment for us, as you can imagine, and we feel especially bad for the patients."

It also hammered the company stock, which dropped 63 percent to $9.26 this morning, from its Friday close price of $25.16.

Dermira plans to shutter the program and move on to more promising compounds. John Carroll, writing for Endpoints News, said, "Failure did not come cheap for Dermira, which recruited 1,500 patients for the studies. But the company does have other drugs to turn to, including DRM04, which is supposed to reduce sweating in kids. The biotech also bought lebrikizumab from Roche after the pharma giant produced some disappointing data for the drug, now being studied for atopic dermatitis."

Umer Raffat, an analyst with Evercore ISI, wrote in a note, "This is a name that I had flagged as carrying 65 percent probability going into the phase III trial based on our prior analysis plus the consistency of DRM01’s data form Phase IIa and IIb … clearly that didn’t pan out. I clearly stand corrected."

Wiggans noted in a statement, "We remain dedicated to bringing new treatments to people living with chronic, underserved skin conditions. As we look ahead, we are focused on building a commercial organization to support the anticipated launch of glycopyrronium tosylate for axillary hyperhidrosis later this year, subject to FDA approval, as well as our Phase IIb trial evaluating lebrikizumab as a potential treatment for moderate-to-severe atopic dermatitis, for which we expect to announce topline data in the first half of 2019."

A decision for the axillary hyperhidrosis drug, DRM04, is expected by the U.S. Food and Drug Administration (FDA) on June 30.

Register as Visitor to CPhI China 2018!